The R3 Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only.

Device Description

The R3 Constrained Liners were previously cleared for market notification K083566. In August of 2010, Smith & Nephew launched a voluntary recall of the devices due to reports of intraoperative distocations .- The subject devices have been modified to address the intraoperative failure mode. Design features have been incorporated into the inner locking and support ring components of the R3 Constrained Liner construct which increase the device's resistance to dislocation under dynamic loading. The R3 Constrained Liners are available with inner diameters of 22 and 28mm and outer diameters from 52mm through 66/70mm. The devices are assembled from components that are made of ASTM F75 CoCr, ASTM F90 CoCr, ASTM F1472 Ti-6Al-4V, and ASTM F648 UHMWPE.

AI/ML Overview

The provided text describes a medical device submission (K111635) for a modified R3 Constrained Liner to the FDA. The submission focuses on demonstrating substantial equivalence to previously cleared devices through mechanical testing, not through a clinical study involving human readers or AI. Therefore, most of the requested information regarding acceptance criteria for AI performance, sample sizes for test sets, expert involvement, and ground truth establishment, is not applicable to this document.

However, I can extract the relevant information regarding the device itself and the type of evaluation performed.

Here's a breakdown of the information based on your request and what's available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative, measurable format like a table for specific performance metrics (e.g., accuracy, sensitivity, specificity) as one would expect for an AI/CADe device. Instead, the "acceptance criteria" for this device, which is a physical implant, are implicitly met by demonstrating substantial equivalence to predicate devices through mechanical testing.

The "reported device performance" is a qualitative statement of equivalence.

Performance Aspect	Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical	The modified R3 Constrained Liner components must demonstrate sufficient attachment loads (push-in, push-out, shuck-out) and increased resistance to dislocation under dynamic loading, equivalent to existing, legally marketed predicate devices, and demonstrate no new issues related to safety and effectiveness. This is in response to a previous recall due to intraoperative dislocations.	"Mechanical testing has been conducted to address the attachment loads (push-in, push-out, shuck-out) of the R3 Constrained Liner components as well as to address the new failure mode (dislocation). A review of the results indicates that the R3 Constrained Liners are equivalent to existing, legally marketed predicate devices with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices."
Overall	The modified R3 Constrained Liner must be substantially equivalent to the predicate devices (K083566, K021803, K033442) in terms of function, intended use, indications for use, material composition, and overall design.	"The subject devices are identical in function, intended use, indications for use, and material composition, and very similar in overall design to the R3 Constrained Liners cleared via premarket notification K083566." "Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to above predicate constrained hip systems."

The following points are not applicable to this submission because it is for a physical medical device (hip implant), not an AI/CADe device that performs analysis or diagnosis. The evaluation was based on mechanical testing and comparison to predicates, not a clinical study involving experts or human-in-the-loop performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This document describes mechanical testing of a physical device, not a test set for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. Ground truth for an AI algorithm is not relevant here. The "ground truth" for this device would be its mechanical integrity, which is assessed through engineering tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. There was no test set in the context of AI evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. No MRMC study was conducted, as this is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. The "ground truth" for the device's performance would be the results of the mechanical tests proving its structural integrity and resistance to dislocation.

8. The sample size for the training set

Not Applicable. There is no AI training set for this physical device.

9. How the ground truth for the training set was established

Not Applicable. There is no AI training set.

Summary

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K111635. lot 2

We are smith&nephew

Submitted by:

Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road

EP - 9 2011

Memphis, Tennessee 38116 Date of Summary: June 9, 2011 Megan Bevill, Regulatory Affairs Project Manager Contact Person and Address: T (901) 399-5340 F (901) 566-7086 Smith & Nephew, Inc. R3 Constrained Liner Name of Device: Common Name: Acetabular Liner, Constrained 21 CFR 888.3310 Hip joint metal/polymer constrained Device Classification Name and cemented or uncemented prosthesis Reference: Device Class: Class II Panel Code: Orthopaedics/87 KWZ Product Code:

Device Description

The R3 Constrained Liners are available with inner diameters of 22 and 28mm and outer diameters from 52mm through 66/70mm. The devices are assembled from components that are made of ASTM F75 CoCr, ASTM F90 CoCr, ASTM F1472 Ti-6Al-4V, and ASTM F648 UHMWPE.

Technological Characteristics

Mechanical testing has been conducted to address the attachment toads (push-in, push-out, shuckout) of the R3 Constrained Liner components as well as to address the new failure mode (dislocation), A review of the results indicates that the R3 Constrained Liners are equivalent to existing, legally marketed predicate devices with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.

Intended Use

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Substantial Equivalence Information

The subject devices are identical in function, intended use, indications for use, and material composition, and very similar in overall design to the R3 Constrained Liners cleared via premarket notification K083566. "

Table 1: Substantially equivalent predicates to the R3 Constrained Liner

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew, Inc.	R3 Constrained Liner	K083566	3/3/2009
Smith & Nephew, Inc.	Reflection Constrained Liners	K021803	12/19/2002
Smith & Nephew, Inc.	Reflection Constrained Liners	K033442	11/26/2003

Conclusion

As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the modified R3 Constrained Liners. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to above predicate constrained hip systems.

Confidential

ર-2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MIJ-20993-0002

Smith & Nephew. Inc. % Ms. Megan Bevill Regulatory Affairs Project Manager 1450 Brooks Road Memphis, Tennessee 38116

SEP - 9 2011

Re: K111635

Trade/Device Name: R3 Constrained Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained or uncemented prosthesis Regulatory Class: II Product Code: KWZ Dated: June 9, 2011 Received: June 13, 2011

Dear Ms. Bevill:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Megan Bevill

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 53) -542 of the Act): 21 CFR 1000-1050.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

hup://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Eric Keith

-S. Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Indications for Use Statement

510(k) Number (if known):

Device Name: R3 Constrained Liner

Indications for Use:

The R3 Constrained Liner Acetabular System is a cemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only.

Prescription Use __ X (Part 21 CFR 801.109)

AND/OR

Over-the-Counter Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for M.Melkern
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111635

Page 1 of 1

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Regulation Number and Section

§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”